Grafton DMB Matrix bone graft recalled for potential outer pouch defects
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a precautionary Class II recall based on a manufacturing process deviation with no reported adverse events or injuries. The hazard is theoretical—potential non-conformances in outer packaging—rather than confirmed device defects or patient harm.
Plain-English summary
Medtronic Sofamor Danek USA Inc has recalled 377 units of Grafton DMB Matrix demineralized bone matrix (Model Numbers T42200 and T42210) due to potential defects in the outer Tyvek pouch packaging. Specific serial numbers are affected.
The recall was initiated because a required inspection step for the outer Tyvek pouch may not have been performed according to specifications during manufacturing. As a result, some batches may have been released with non-conformances in the outer pouch that were not detected.
The affected devices were distributed in the United States, Colombia, South Korea, New Zealand, India, and Taiwan. A complete list of affected serial numbers is available in the FDA recall notification Z-0163-2024.
No adverse events or patient injuries have been reported. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 377
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) T42200: GTIN 00643169123052
- Serial Numbers: A59254-013
- A57871-018
- A59117-013
- A59254-018
- A59264-016
- A58526-014
- A58526-015
- A58526-016
- A58864-018
- A58082-016
- A58983-011
- A58983-012
- A59320-013
- A59320-016
- A57043-011
- A58831-018
- A59307-012
- A59320-019
- A58831-019
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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